ZonMw: The Netherlands Organisation for Health Research and Development
Age
23–69
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
Female
Age 23-69
BMI 18-35 - stable weight, no fluctuations
Have undergone a total mastectomy at least 3 months prior the study, whether therapeutic or prophylactic, whether unilateral or bilateral, with no resection of the pectoralis muscle
Agrees to have reconstruction at the time of study involving only autologous fat grafting (AFT)
Assessed by surgeon to have enough donor fat
Passes a 20-minutes tolerance test with EVEBRA Device. (Patient will be fitted, instructed on the use, and given the EVEBRA Device to try in the office for 20 minutes. She passes if she tolerates its use, feels comfortable wearing it, and is able to comply with the required wear of the device.)
You may not be if
untreated breast cancer
history of radiation therapy on the involved breast, even if it was part of a previous breast conservation procedure
completed chemotherapy course less than 2 months prior (acceptable to still be on aromatase inhibitors)
except for the biopsy leading to the diagnosis of cancer, had surgery to breast prior to the mastectomy (e.g., multiple biopsies, implant augmentation, mastopexy, fat grating)
had mastectomy wound healing complications, e.g., seroma, wound breakdown, infection
mastectomy defect/scar has significant skin excess and deep folds adherent to the chest wall
has a pacemaker or aneurysm clips
pregnancy or breastfeeding
had a cardiac stent placed within the last 2 months
claustrophobic, as reported by patient
known current substance abuse, as reported by patient
history of silicone allergy, as reported by patient
history of Gadolinium allergy, as reported by patient
history of lidocaine allergy, as reported by patient
bleeding diathesis, whether primary or iatrogenic, as reported by patient cigarette smoker and/or Smokeless cigarette smokers, as reported by patient
medical conditions that preclude breast reconstruction including uncontrolled hypertension or diabetes, renal failure, steroid dependent asthma, and on immuno- suppressant medications, as reported by patient
Clareo Health | External Vacuum Expansion: Evaluation in Breast Reconstructive Surgery Evaluation in Breast Reconstructive Surgery
